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Ambroxol hydrochloride containing hydroxypropyl beta-cyclodextrin and its preparation

A kind of ambroxol hydrochloride injection and the technology of ambroxol hydrochloride, which are applied in the field of medicine and achieve the effects of facilitating clinical medication and solving water-soluble problems

Inactive Publication Date: 2006-06-21
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It utilizes the inclusion effect of hydroxypropyl β-cyclodextrin on ambroxol, thereby completely solving its water solubility problem, making ambroxol hydrochloride compatible with alkaline drugs and convenient for clinical use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0005] Example 1: Weigh 6 parts of 200mg ambroxol hydrochloride, place them in 100ml beakers respectively, add 20ml of distilled water to dissolve, add 1000mg, 2000mg, 3000mg, 4000mg and 5000mg of 2-hydroxypropyl β- Cyclodextrin, after being dissolved, adjust the pH value to about 8.5 with 0.01mol / L sodium hydroxide solution, the results are shown in Table 1.

[0006] pH value

[0007] It can be seen from the table that when the pH value is greater than 8.5, the weight ratio of the drug to hydroxypropyl β-cyclodextrin is less than 1:15, and the precipitate is folded; while the weight ratio of the drug to hydroxypropyl β-cyclodextrin is greater than 1:15 When (including 1:15), no precipitation is folded out.

Embodiment 2

[0008] Example 2: When the weight ratio of drug to 2-hydroxypropyl β-cyclodextrin is 1:3, drug precipitation under different pH conditions is investigated. The method is the same as "Example 1", and the results are shown in Table 2.

[0009] pH value

Embodiment 3

[0010] Example 3: When the weight ratio of drug to 2-hydroxypropyl β-cyclodextrin is 1:5, drug precipitation under different pH conditions is investigated. The method is the same as "Example 1", and the results are shown in Table 3.

[0011] pH value

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PUM

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Abstract

The present invention is a hydroxypropyl β-cyclodextrin-containing ambroxol hydrochloride injection and a preparation method thereof, which completely solves the problem of water solubility, so that various injection preparations can be prepared. Ambroxol hydrochloride injection contains hydroxypropyl beta-cyclodextrin. The injection is realized by adding "2-hydroxypropyl β-cyclodextrin" to solve the solubility of ambroxol hydrochloride in high pH water, wherein "ambroxol hydrochloride" and "2-hydroxypropyl β-cyclodextrin" The weight ratio of "cyclodextrin" is 1:3 to 1:50. Said injection includes "injection", "lyophilized powder injection", "sterile powder injection", "ambroxol hydrochloride glucose, sodium chloride injection or glucose sodium chloride injection". The present invention can make ambroxol hydrochloride compatible with basic drugs, and is convenient for clinical medication.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to ambroxol hydrochloride injection containing hydroxypropyl beta-cyclodextrin and a preparation method thereof. Background technique: [0002] Ambroxol hydrochloride is a metabolite of bromhexine, and its expectorant effect is stronger than that of bromhexine. Ambroxol hydrochloride has been widely used in the treatment of respiratory diseases in many countries such as the United States, Britain, Germany, Japan, etc., with excellent clinical effects and almost no toxic side effects. Its efficacy and safety have been clinically confirmed. The pharmacological effects include: 1. Dissolving mucus; 2. Promoting the synthesis of pulmonary surfactant; 3. Activating the purification function of mucus cilia; 4. Reducing the adhesion between sputum and cilia, making sputum easy to cough up. Tests have shown that ambroxol can protect against peroxide-induced lung damage including asthma, ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/136A61K47/40A61K9/08A61K9/19A61P11/10A61K31/13
Inventor 邓意辉
Owner SHENYANG PHARMA UNIVERSITY
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